Specialist, Regulatory Affairs- Medical Device - Schaumburg - Sunstar

    Sunstar
    Sunstar Schaumburg

    4 days ago

    Description

    Specialist, Regulatory Affairs- Medical Device

    Sunstar Americas fosters a collaborative culture that ensures high-quality products to consumers and professionals. Our team-oriented approach encourages creative thinking and a positive work environment.

    • This role supports regulatory submissions, product registrations, technical files preparation and lifecycle management for medical devices in the US Canada LATAM regions with Class I II medical devices combination products Experience international medical device/cosmetic/drug registration is desired especially Brazil Colombia Argentina Mexico Europe export documentation management GUDID/UDI Adverse Events reporting to the FDA are also required skills include working knowledge of US FDA Health Canada computerized submission systems excellent written verbal communication proficiency in MS Office applications good interpersonal organizational abilities travel may be required daily tasks would involve under supervision coordinating compiling submitting regulatory applications ensuring compliance with applicable regulations standards maintaining policies procedures quality system updating listing database travel driving meetings seminars appropriate factors health wellness expertise teamwork High Quality Products diversity inclusion corporate responsibility insurance comprehensive benefits vacation pet Legal Identity Theft Plans Corporate Perks Discounts hybrid schedule employee appreciation events recognition rewards programs The pay range for this position is $79002 - $119853 bonus offered depending on performance location

  • Work in company

    Medical Device Sales Representative

    Only for registered members

    Want to be a part of something great happening in the healthcare field? Our client is an early stage company offering a next generation enteral access platform featuring proprietary feeding tube placement technology. · ...

    Chicago

    1 month ago

  • Work in company

    Medical Device Sales Representative

    Only for registered members

    Want to be a part of something great happening in the healthcare field? Our client is an early stage company offering a next generation enteral access platform featuring proprietary feeding tube placement technology. · ...

    Chicago

    1 month ago

  • Work in company

    Project Manager- Medical Devices

    Only for registered members

    Job summary · Project Manager- Medical Devices · We are hiring Project Manager-Medical Devices for one of our clients. · We specialize in Contingent hiring Direct Hires Statement of Work Payroll Management IC Compliance VMS RPO and Managed IT Services. ...

    Schaumburg

    1 month ago

  • Work in company

    Specialist, Regulatory Affairs- Medical Device

    Only for registered members

    As a member of the Sunstar Group, Sunstar Americas, Inc., a global organization dedicated to improving overall health through oral health worldwide, holds a prominent position in the oral care industry. Formerly known as the John O. Butler Company, we are renowned for our excepti ...

    Schaumburg $83,204 - $124,806 (USD)

    3 days ago

  • Work in company

    Regulatory Affairs Specialist- Medical Devices

    Only for registered members

    Regulatory Affairs Specialist- Medical Devices role at Sunstar Americas, Inc. involves supporting the preparation of regulatory 510(k) submissions and assisting international business partners with product registrations. · BS in Science or Medical / Healthcare related field or hi ...

    Schaumburg $66,847 - $100,273 (USD)

    1 month ago

  • Work in company

    Specialist, Regulatory Affairs- Medical Device

    Only for registered members

    At Sunstar Americas, Inc., we firmly believe that our people are the foundation of our success. We foster a collaborative, innovative, and agile culture that ensures we deliver high-quality, innovative products to consumers and oral care professionals. Our team-oriented approach ...

    Schaumburg, Illinois, United States

    1 week ago

  • Work in company

    Design Transfer Engineer-Medical Device

    Only for registered members

    We are hiring Design Transfer Engineer for one of our clients. · Bachelor's Degree in Electrical, Manufacturing, or Biomedical Engineering or equivalent required. · Regulated Industry Experience · Medical Device Manufacturing process validation experience preferred · ...

    Schaumburg

    1 month ago

  • Work in company

    Specialist, Regulatory Affairs- Medical Device

    Only for registered members

    Join us and become part of our global team at Sunstar Americas Inc., where together we can achieve success and contribute to a better future. We are seeking a Regulatory Affairs Specialist- Medical Device with experience in the US and Canada regulated industry. · ...

    Schaumburg, IL

    2 months ago

  • Work in company

    Medical Device

    Only for registered members

    Responsible for quality of assigned New Product Introduction (NPI) combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency ...

    North Chicago

    3 weeks ago

  • Work in company

    Medical device engineer

    Only for registered members

    · Company Description · About Collabera: · Established in 1991, Collabera is one of the fastest growing end-to-end information technology services and solutions companies globally. As a half a billion dollar IT company, Collabera's client-centric business model, commitment to se ...

    North Chicago, IL, USA, North Chicago, IL $80,000 - $150,000 (USD) per year

    1 week ago

  • Work in company

    Medical Device Test Technician

    Only for registered members

    We are seeking a Medical Device Test Technician to drive projects through the product verification process for Hugo RAS. The ideal candidate will have a results-driven work ethic, collaborative spirit, and solution facilitation skills. · ...

    Buffalo Grove

    2 weeks ago

  • Work in company

    Medical Device Quality Engineering

    Only for registered members

    +Hybrid quality engineering role in medical device field with 10 hours on-site work per week and ability to work remotely. · +New equipment IQ/OQ/PQ process validationID of risk controls and supporting product failure investigationsExperience in the medical device field (especial ...

    Lake Zurich

    2 weeks ago

  • Work in company

    Medical Device Quality Consultant

    Only for registered members

    Medical device quality consultant needed for 4–6-month contract. Requirements include BS in relevant scientific or engineering discipline and experience in medical device field as quality engineer. Work will be hybrid with on-site presence in Lake Zurich. ...

    Lake Zurich

    1 month ago

  • Work in company

    Medical Device Quality Engineering

    Only for registered members

    We are seeking a Quality Engineering Consultant to join our team. As a Quality Engineer in the medical device field, you will be responsible for ensuring the quality of our products and processes. · ...

    Lake Zurich, IL

    2 weeks ago

  • Work in company

    Medical Device Safety Reviewer

    Only for registered members

    The Medical Device Safety Reviewer supports post-market safety surveillance activities for medical devices. This role focuses on evaluating adverse event reports and conducting medical safety assessments to ensure timely and accurate safety reporting. · Evaluate seriousness of ad ...

    Chicago $40 - $45 (USD)

    1 month ago

  • Work in company

    Design Controller-Medical Devices

    Only for registered members

    GN Hearing Care busca un Design Controller para su equipo de Investigación y Desarrollo. Se requiere experiencia en Diseño Control y regulaciones médicas. · Planificar y ejecutar entregables del control del diseño para proyectos SW médicos. · Escribir o gestionar la elaboración d ...

    Glenview $95,000 - $105,000 (USD) Full time

    3 weeks ago

  • Work in company

    Medical Device Sales Consultant

    Only for registered members

    Are you a proven medical sales professional ready to make a meaningful impact in healthcare? We're seeking an experienced Sales Consultant to join our dynamic team and help hospitals deliver better patient outcomes through cutting-edge medical devices and disposables. · ...

    Chicago

    1 month ago

  • Work in company

    Medical Device Sales Specialist

    Only for registered members

    Sales specialist for medical devices in Endoscopic Sinus Surgery market to ENTs. · ...

    Chicago

    1 month ago

  • Work in company

    Medical Device Lab Technician

    Only for registered members

    Position Overview · The Medical Education Lab Technician ensures all lab events run smoothly by preparing instruments, organizing equipment, maintaining sterile/clean environments where required, and coordinating logistics for incoming and outgoing training materials. Candidates ...

    Chicago

    3 days ago

  • Work in company

    Medical Device Sales Representative

    Only for registered members

    THE COMPANY: · This medical device manufacturer provides safety solutions to over 10,000 hospitals and surgery centers across the globe. · The sales team is ready to hire a highly motivated Territory Sales professional who will help to manage and grow business across the greater ...

    Chicago $65,000 - $135,000 (USD) per year

    1 day ago

  • Work in company

    Medical Device Sales Specialist

    Only for registered members

    We are seeking an Oncology Specialist to sell our products within the Eastern Region of the United States. · Build and maintain strong relationships with healthcare professionals. · Develop effective sales strategies to achieve sales targets. · ...

    Bolingbrook

    1 month ago

Jobs
>
Schaumburg